These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

3,615 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Kidney Test Recalled for 100 Units in 2025

GET TESTED INTERNATIONAL AB recalled 100 Kidney Test devices sold nationwide in the United States. The recall cites distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow manufacturer instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Serotonin Test Recall 12 Units (2025)

GET TESTED INTERNATIONAL AB recalled 12 serotonin test devices distributed nationwide in the United States after the device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions. Contact GET TESTED INTERNATIONAL AB for instructions or consult your healthcare provider.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB MPOX Test Recall for 4 Units Distributed in US (2025)

GET TESTED INTERNATIONAL AB recalled 4 MPOX Test devices distributed nationwide in the United States after distribution without premarket approval. The recall cites a regulatory violation rather than an injury risk. Healthcare providers and patients should stop using the device immediately and await instructions from the manufacturer.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Gonorrhea Test Recalled for 463 Units in 2025

GET TESTED INTERNATIONAL AB's gonorrhea test was distributed nationwide in the United States. The recall cites distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the test immediately and follow the manufacturer's recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Iodine Test Recall 2025 for 13 Units

GET TESTED INTERNATIONAL AB recalled 13 iodine test devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Get Tested International AB HSV Test Kit Recalled for 1,361 Units in 2025

Get Tested International AB recalled 1,361 HSV-1 and HSV-2 Test Kits distributed nationwide in the United States after regulators found distribution without premarket approval. The test kit lacks FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions by contacting Get Tested International AB.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Biological Age & Longevity Test Recalled for Premarket Issue (3 Units,  

GET TESTED INTERNATIONAL AB recalled 3 units of the Biological Age & Longevity Test distributed nationwide in the United States. The recall concerns distribution without premarket approval or clearance. Consumers should stop using the device and follow the manufacturer's instructions. Contact GET TESTED INTERNATIONAL AB for guidance.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalled Gut Microbiome Test Mega (2 Units) Over Premarket Approval Viol

GET TESTED INTERNATIONAL AB recalled 2 Gut Microbiome Test Mega units distributed nationwide in the United States. The recall centers on distribution without premarket approval or clearance. Consumers should stop using the device and contact the manufacturer for instructions. The notice was issued in 2025 and is currently active.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB D-Dimer Test Recall for 1,218 Units (2025)

GET TESTED INTERNATIONAL AB recalled 1,218 D-Dimer Test kits nationwide after distributing without premarket approval. The recall cites distribution without FDA premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow all recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB PSA Test Recall 27 Units Distributed Nationwide 2025

GET TESTED INTERNATIONAL AB recalled 27 PSA Test devices distributed nationwide in the United States on 2025-11-03 after regulators found the device was distributed without premarket approval or clearance. The lack of PMA/clearance means the device did not receive required regulatory authorization before sale. Patients and healthcare providers should stop using the device immediately and follow 제조

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Mycotoxin Panel Test Recalled for 2 Units in 2025

GET TESTED INTERNATIONAL AB's Mycotoxin Panel Test was recalled after two units were distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions or contact a healthcare provider for guidance.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Fructose Intolerance Test Recalled for 8 Units (2025)

GET TESTED INTERNATIONAL AB recalled 8 Fructose Intolerance Test devices distributed nationwide in the United States. The recall cites distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Akkermansia Test Recalled for 24 Units (2025)

GET TESTED INTERNATIONAL AB’s Akkermansia Test recall covers 24 units distributed nationwide in the United States. The device was distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalls 6 Gut Microbiome Test Small Kits for Premarket Approval Violat​e

GET TESTED INTERNATIONAL AB recalled 6 Gut Microbiome Test Small units distributed nationwide in the United States. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Trichomonas Vaginalis Test Recalled for Lack of Premarket Approval (2025

GET TESTED INTERNATIONAL AB recalled 60 Trichomonas Vaginalis tests distributed nationwide in the United States after regulators found no premarket approval or clearance. The recall stems from a violation of regulatory requirements. Patients and healthcare providers should stop using this device immediately and follow the manufacturer’s recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Food Sensitivity Test Large Recalled for 3 Units in 2025

GET TESTED INTERNATIONAL AB recalled 3 units of its Food Sensitivity Test Large sold nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Consumers should stop using it and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.

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Health & Personal Care
HIGH
FDA DEVICE

GET TESTED INTERNATIONAL AB Recalled 6 Food Intolerance Test Large Units for Premarket Issue (2025)

GET TESTED INTERNATIONAL AB recalled 6 Food Intolerance Test Large units sold nationwide in the US after a premarket approval issue. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB or their healthcare provider for instructions.

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